Index

Drug Shortages Worsen: Lives at Stake

Last year the U.S. General Accountability Office (GAO) issued a report showing sharp increases in the numbers of medicines in critical shortage in the United States, and therefore, worldwide. Drugs in short supply are designated “critical” if safe alternatives do not exist. The duration of these effective outages averaged nine months, during which time some cancer patients had no chemotherapy, surgeons scrambled to find anesthesia, and nutritional supplements for key patient groups went missing entirely. Every year since 2006 the numbers of critical shortage episodes has increased.

The GAO recommended Congress order the Food and Drug Administration to create critical drugs lists, monitor supplies, and issue warnings to the pharmaceutical industry in search of substitute manufacturers before supplies entirely disappeared.

Meanwhile the Infectious Diseases Society of America (IDSA) has tracked a steady increase in outages for antibiotics and other anti-infection agents. These have included acyclovir (for herpes), amikacin, erythromycin, ciprofloxacin, mupirocin, penicillin G, polymyxin B, streptomycin and sulfamethoxazole-trimethoprim (antibiotics), isoniazid (TB) and many more. According to IDSA, “Today shortages are often due to product quality (54 percent), capacity issues (21 percent), manufacturers halting production (11 percent), and other reasons (14 percent).”

Though the FDA currently has little authority over the supply side of medicines, manufacturers are required under the Food, Drug, and Cosmetics Act to give the agency six months’ notice if they intend to cease production of a medicine that they solely make. Even if notification occurs, there is little the FDA can do shy of issuing a bulletin and hoping that a company steps up to the plate. In October 2011 President Barack Obama signed an Executive Order empowering the FDA to proactively inspect drug production capacity for critical medicines, identifying potential shortfalls and outages before they reach critical stages. Not surprisingly, the outages are primarily among off-patent drugs with low profit potential – the FDA is hard-pressed to lure alternative manufacturers. Examples include Doxil, used to treat uterine cancer; mitomycin for bladder cancer; medicines for attention deficit disorder; a host of cardiology drugs; most injectable medicines for heart treatment. Officials in the Obama Administration say nearly all shortages arise from the generics industry, which operates on especially short profit margins. In February 2012 the FDA, drawing on Obama’s Executive Order authority, authorized importation of several cancer drugs, purchased from overseas generic manufacturers.

Despite such initiatives from the FDA, the American Society of Health System Pharmacists says drug outages are nearing “national crisis situation” status, particularly for cancer drugs, anesthetics and cardiovascular treatments.

Physicians have taken to bartering for medicines with neighboring hospitals, rationing supplies, even triaging access according to the severity of patients’ conditions. In some cases even these measures have proven inadequate, and cancer patients have deteriorated for lack of treatment. Still other patients are going without treatment because the acute shortages have led to price-gouging, driving costs far beyond insurance coverage levels.

Most of the critical shortages tracked by the FDA involve sterile injectable drugs. According to the agency, manufacturers are unable to make uncontaminated, safe products, and shortfalls or outages are now critical for 130 products. In some cases the sterility issues stem from soaring demand for generic drugs, amid cost-saving efforts from insurance companies and Medicare. Manufacturers have had trouble building capacity to meet rising demand, often cutting corners in production or deleting entire product lines to make way for manufacture of higher-demand medicines.

The FDA maintains a Biologics Product Shortages List, tracking critical problems in bioengineered and cell-based medicines. In 2011 more than half the products on that list were vaccines, most indented to protect children from common diseases such as measles and pertussis. Bryan Liang of San Diego State University has shown that desperate physicians and hospitals are turning to internet-based “pharmacies” to fill vaccine orders -- a practice that is safe for authorized sites, but may be quite dangerous when purchasers turn to unverified international distributors. The National Association of Boards of Pharmacy offers a system of Verified Internet Pharmacy Practice Site (“VIPPS”) certification, guiding consumers to legitimate online sellers. But Liang’s work demonstrates many physicians and clinical pharmacies are unaware of the VIPPS significance, and are filling short supplies with products sold by dubious suppliers that may be unreliably manufactured or stored in unsafe conditions. (No hyperlink offered as Liang’s work is in Elsevier’s publication Vaccinedoi:10.1016/j.vaccine.2011.11.016.Elsever does not allow links to full papers without payment.)

Several bills seeking to address the problem have been introduced in the U.S. House and Senate over the last year, but none have reached voting. The overall problem is that Congress seeks a role for the FDA, wants to broaden the agency’s powers in the arena, but declines to provide the agency with funding to pay for its increased work load.